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RECRUITING
NCT07500987
PHASE1

Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of \[111In\]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.

Official title: A Phase I Multicentre Open-label Study to Evaluate Safety, Tolerability, and Dosimetry of [111In]-FPI-2107 in Chinese Adult Participants With EGFR Mutation-positive NSCLC

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-02-27

Completion Date

2026-07-21

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

[111In]-FPI-2107

radioimmuno-SPECT agent

DRUG

FPI-2053

unconjugated/unlabelled bispecific antibody \[cold\]

Locations (3)

Research Site

Beijing, China

Research Site

Shandong, China

Research Site

Wuhan, China